Syllabus | Pharmacovigilance | B. Pharmacy

Course: B. Pharmacy 8thSem/ 4th year

Name of Subject: Pharmacovigilance

Subject Code:  BP 805ET

S No.

Topic

Domain

Hours
Introduction to Pharmacovigilance

History and development of Pharmacovigilance , Importance of safety monitoring of Medicine

WHO international drug monitoring programme , Pharmacovigilance Program of  India(PvPI)

Introduction to adverse drug reactions

Definitions and classification of ADRs , Detection and reporting , Methods in Causality assessment , Severity and seriousness assessment, Predictability and preventability assessment Management of adverse drug reactions
Basic terminologies used in pharmacovigilance
Terminologies of adverse medication related events, Regulatory terminologies

Nice to know

Must know

Must know

Must know

10
2. Drug and disease classification

Anatomical, therapeutic and chemical classification of drugs

International classification of diseases

Daily defined doses

International Non proprietary Names for drugs
Drug dictionaries and coding in pharmacovigilance

WHO adverse reaction terminologies

MedDRA and Standardized MedDRA queries

WHO drug dictionary

Eudravigilance medicinal product dictionary
Information resources in pharmacovigilance

Basic drug information resources

Specialised resources for ADRs
Establishing pharmacovigilance programme

Establishing in a hospital

Establishment & operation of drugsafety department in industry

Contract Research Organisations (CROs)

Establishing a national programme

Nice to know

Desirable to know

Nice to know

Must know

Must know

Must know

Must know

Must know

Must know

Nice to know

10
3. Vaccine safety surveillance

Vaccine Pharmacovigilance

Vaccination failure

Adverse events following immunization
Pharmacovigilance methods

Passive surveillance – Spontaneous reports and case series

Stimulated reporting

Active surveillance – Sentinel sites, drug event monitoring and registries

Comparative observational studies – Cross sectional study, case control study and cohort study
Targeted clinical investigations
Communication in pharmacovigilance

Effective communication in Pharmacovigilance
Communication in Drug Safety Crisis management
Communicating with Regulatory Agencies, Business Partners, Healthcare facilities & Media

Nice to know

Must know

Must know

Must know

Desirable to know

Must know

Must know

Must know

Must know

Must know

Must know

10
4. Statistical methods for evaluating medication safety data
Safety data generation

Pre clinical phase

Clinical phase

Post approval phase
ICH Guidelines for Pharmacovigilance

Organization and objectives of ICH
Expedited reporting
Individual case safety reports
Periodic safety update reports
Post approval expedited reporting
Pharmacovigilance planning
Good clinical practice in pharmacovigilance studies

 

Nice to know

Must know

Must know

Desirable to know

Must know

Must know

Must know

Must know

8
      5. Pharmacogenomics of adverse drug reactions

Drug safety evaluation in special population

Paediatrics, Pregnancy and lactation, Geriatrics
CIOMS

CIOMS Working Groups, CIOMS Form
CDSCO (India) and Pharmacovigilance

D&C Act and Schedule Y Differences in Indian and global pharmacovigilance requirements

Desirable to know

Must know

Must know

Must know

7